Utility of CrocsRx Clog as a Diabetic House Shoe: a Pilot Study
Do CrocsRx Clogs Reduce Dynamic Plantar Pressure as Compared to Conventional House Shoes in Subjects With Diabetes?
1 other identifier
interventional
45
1 country
1
Brief Summary
Foot complications are a common and costly problem for subjects with diabetes. Although Medicare provides a pair of diabetic shoes yearly for subjects with diabetes, many do not wear their diabetic shoes in and around their house. Instead, subjects may wear shoes, such as flip flops or slippers, that provide little to no protection against injuries. While proper house shoe is important in the prevention of diabetic foot complications, this area has not received much attention. The purpose of this pilot study is to assess if CrocsRx Medical silver cloud clogs - a lightweight clog with protective toe box, cushioning soles, and easy to don and doff - offer reduced dynamic plantar pressure magnitude, as compared to conventional house shoes, for subjects with diabetes. A Repeated Measures ANOVA study design will be used to assess dynamic plantar pressure in 2 shod conditions for each subject with the order of shoes randomized.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Oct 2014
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2014
CompletedFirst Posted
Study publicly available on registry
August 29, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMay 13, 2015
May 1, 2015
1 year
August 27, 2014
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of peak pressure sub-metatarsal 2 and hallux in usual house shoes versus the CrocsRx clogs
In-shoe plantar pressures will be measured using novel pedar-X system on subjects with diabetes while walking in 2 shod conditions: (1) their usual house shoe and (2) the CrocsRx clogs.
At visit 1.
Study Arms (1)
Typical house shoe
EXPERIMENTALSubject's typical shoes worn in and around home
Interventions
Eligibility Criteria
You may qualify if:
- Male or female between the ages of 21 and 75 (inclusive)
- Documented type 1 or type 2 diabetes mellitus
- Demonstrated abnormal foot biomechanics by the presence of intractable plantar keratoma (IPK) beneath metatarsal heads or hallux
- Participants with and without signs of peripheral neuropathy (unable to perceive a 10 gram monofilament or vibration perception threshold (VPT \> 25 Volts)
- Able to walk independently without the use of walking aids (cane, crutches, or walker)
- Able to speak and understand English
- Able to understand the information in the consent form and willing and able to sign the consent form
You may not qualify if:
- History of lower limb amputations (excluding toe amputations)
- Presence of cutaneous ulceration in the lower extremity
- History of or active Charcot neuroarthropathy of either foot
- Severe peripheral vascular disease (i.e. ischemic rest pain, 2-block claudication, or gangrene)
- End stage kidney disease requiring hemodialysis, stroke, or widespread malignant disease
- Pregnant or nursing
- Not willing or able to make the required follow-up visits
- Insufficient (corrected) vision to complete the questionnaire
- Unable to fit into available shoe sizes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gait Study Center at the Temple University School of Podiatric Medicine
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Gait Study Center
Study Record Dates
First Submitted
August 27, 2014
First Posted
August 29, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
May 13, 2015
Record last verified: 2015-05